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Adverse Events During Physical Therapy in Neurocritical ICU Patients

Clinicopathological Analysis of Factors Associated With the Development of Adverse Events During Physical Therapy Intervention in Neurocritical Patients in the Intensive Care Unit

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07901140
Enrollment
47
Registered
2026-10-28
Start date
2026-09-23
Completion date
2026-10-31
Last updated
2026-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Brain Injury, Stroke, Subarachnoid Hemorrhage, Brain Neoplasms, Orthostatic Intolerance

Keywords

Early Mobilization, Neurocritical Care, Physical Therapy, Intensive Care Unit, Hemodynamic Stability

Brief summary

The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are: What clinical, neurological, hemodynamic, and respiratory factors are associated with adverse events during physical therapy in neurocritical patients? What is the incidence and type of adverse events that occur most frequently during physical therapy in this patient population? Researchers will compare clinical and physiological data between patients who experienced adverse events during physical therapy and those who did not, to determine risk factors associated with these complications. Participants' data will be retrospectively collected from medical records without performing new clinical interventions.

Interventions

Physical therapy and mobilization procedures administered to neurocritical patients during their ICU stay as recorded in medical, nursing, and physical therapy notes. Retrospective data collection evaluates baseline clinical-pathological risk profile and monitoring parameters (hemodynamics, neurological, respiratory).

Sponsors

Hospital H+ Queretaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (18 years or older) admitted to the Intensive Care Unit (ICU). * Patients classified with a neurocritical condition (e.g., ischemic or hemorrhagic stroke, brain tumor, aneurysm, traumatic brain injury, subarachnoid hemorrhage). * Complete medical records including documentation, notes, and charts from medical, nursing, and physical therapy departments. * Documented physical therapy intervention, vital signs monitoring, neurological scale scores, and pharmacological dosage records.

Exclusion criteria

* Medical records of adult patients admitted to general hospital wards or the emergency department. * Medical records of patients admitted to the Neonatal Intensive Care Unit (NICU). * Medical records of pregnant patients. * Medical records of patients not classified as neurocritical * Medical records of terminal patients or patients receiving palliative care with an estimated life expectancy of less than 24 hours at the time of ICU admission. * Medical records lacking documentation of physical therapy interventions. * Medical records lacking documentation of required hemodynamic and neurological values for risk analysis. * Medical records where collected data does not allow determining the presence or absence of adverse events during physical therapy.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Adverse Events During Physical TherapyDuring the physical therapy session (from initiation up to immediate post-session evaluation, up to 1 hour per session).Presence or absence of any adverse event (binary variable: Yes/No) occurring during or immediately following a physical therapy session in adult neurocritical ICU patients. Adverse events include: hypotension (drop in SBP \> 20 mmHg), hypertension, tachycardia, bradycardia, oxygen desaturation, acute neurological deterioration, increase in intracranial pressure (ICP), or decrease in cerebral perfusion pressure (CPP) requiring therapy session suspension.

Secondary

MeasureTime frameDescription
Clinical and Physiological Predictors of Adverse EventsBaseline assessment immediately prior to each physical therapy session.Association between baseline clinical-pathological variables and the occurrence of adverse events during physical therapy. Evaluated parameters include: Glasgow Coma Scale (GCS), Mean Arterial Pressure (MAP), Richmond Agitation-Sedation Scale (RASS), vasopressor dependence, SpO2/FiO2 ratio (SAFI), external ventricular drain presence, and decompressive procedure history.
Frequency and Specific Types of Adverse EventsDuring each physical therapy session throughout the ICU stay (retrospectively evaluated from October 2023 to April 2026).Distribution and frequency of specific types of adverse events recorded during therapy sessions, categorized into hemodynamic (hypotension, hypertension, tachycardia, bradycardia), respiratory (oxygen desaturation), and neurological (acute deterioration, ICP increase, CPP decrease).
Comparative Analysis of Hemodynamic versus Respiratory VariablesRetrospective evaluation spanning the total ICU stay for each patient record (October 2023 to April 2026).Statistical comparison using Student's t-test to evaluate whether hemodynamic variables show significantly higher association with adverse events compared to respiratory variables.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 29, 2026